Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000489594
Ethics application status
Approved
Date submitted
15/03/2024
Date registered
22/04/2024
Date last updated
22/04/2024
Date data sharing statement initially provided
22/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating treatment outcomes for adolescents with eating disorders
Scientific title
Study protocol for treatment evaluation and predictors of outcome for adolescents with eating disorders in a real world setting
Secondary ID [1] 311740 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 333238 0
Condition category
Condition code
Mental Health 329924 329924 0 0
Eating disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
The study design will be a prospective longitudinal observational cohort study. New individuals engaging with treatment at the Child and Youth Mental Health Service (CYMHS) Eating Disorders Program (EDP) will complete a series of psychometric measures as part of routine practice. Measures are taken at intake, following any changes to service provision (i.e., changing from FBT to CBT-E) and end of treatment. Treatment allocation will be non-randomized according to existing protocol currently operating at CYMHS EDP. Data collected is used to monitor individual/family treatment as part of core practice. If consent to use data for research is provided, it is included in the clinical registry and subsequent analyses. Participants who do not provide consent will receive the same interventions regardless of their involvement in this study

The following interventions are currently in operation at the service, and will be observed as per the current study:

Strong Foundations. Participants engaging in treatment with CYMHS EDP receive the Strong Foundations treatment prior to commencing Family Based Treatment (FBT), Cognitive Behaviour therapy enhanced (CBT-e) or other treatments. The Strong Foundations is a brief (6) week intervention/waitlist management, and involves attending 6 psychoeducation seminars held online, as well as weekly appointments with a medical team member who monitors medical parameters of relevance to ED, and provides psychoeducation, nutritional advice and GP liaison. Further details of Strong Foundations are provided in Sidari et al., (under review).

Family Based Treatment (FBT). Participants engaged with FBT receive the manualized intervention by Lock and Le Grange (2013). FBT consists of family sessions delivered over three phases and focusses on using the family as a resource to help the adolescent recover from the eating disorder. Phase I consists of weekly sessions and aims at charging the parents with the responsibility of correcting the adolescents disordered eating behaviors and low weight. Once disordered eating behaviors are significantly reduced, the treatment moves to Phase II, which consists of returning control over food consumption back to the adolescent in an age-appropriate fashion. Once normal body weight has been restored and eating behavior normalized, Phase III includes more general issues of adolescent development (e.g., increasing autonomy, establishing boundaries).

Cognitive Behavior Therapy-enhanced (CBT-e). Participants engaged with CBT-E receive the manualized intervention by Dalle Grave and Calugi (2020). CBT-E is a manualized transdiagnostic therapy for eating disorders that has been adapted for adolescents. It consists of three stages, over 20 (focused form – for people not significantly underweight), 30 (broad form: for patients with significant external maintaining mechanisms preventing treatment progress) or 40 (for patients with initial BMI < 25th centile for age) sessions. The aims of stage one are to engage the patient in treatment and change, collaboratively create a personal formulation, and establish self-monitoring, regular weighing, and regular eating. Stage two involves addressing the core eating disorder psychopathology, and aims to overcome overvaluation of weight, shape, eating, dietary restraint, and mood and event related eating. If external maintaining mechanisms have been identified (i.e., perfectionism, low self-esteem, interpersonal difficulties), additional modules used to target these mechanisms are added in stage three. Stage three involves ensuring the patient has lasting change by reviewing progress, maintaining mechanisms, and covering a relapse prevention plan.

Eating Disorders Day Program (EDDP). The EDDP is an FBT and Emotion Focused Skills Therapy (EFST)-informed intensive treatment model focusing on identifying and shifting the barriers to treatment through intensifying treatment, and ultimately enabling the participant and family to return to community treatment to continue their recovery journey. Key treatment targets for adolescents include weight restoration, reduction in eating disorder symptoms, anxiety and depression, and return to education. Key treatment targets for parents include increase in self-efficacy, decrease in accommodating and enabling behaviours, and reduction in anxiety and depression symptoms. Adolescents and their families attend EDDP for 10-13 weeks per term for five days per week for no more than 2 successive terms. Further information on the EDDP is detailed in Wilson et al. (2024).
Case Management. Case management is informed by evidence-based models, and involves the clinician/s assessing, planning and implementing options and services to best suit the individual/family’s needs, and is utilized if evidence-based treatments are not suitable or have been discontinued.

Multi-Family Therapy (MFT). MFT is a manualized treatment for eating disorders among children and adolescents (Simic, Baudinet, Blessitt, Wallis, & Eisler, 2021). MFT involves a group of up to eight families that work together with at least two group facilitators and aims to improve outcomes by reducing isolation and stigma, promoting supportive family relationships, skills building and addressing barriers to treatment progress.
Emotion-focused Skills Training (EFST). EFST is a mode of Emotion Focused Family Therapy which has emerging evidence as either a stand-alone or adjunct treatment for eating disorders (Osoro et al., 2022). EFST is based upon the theory that eating disorder behaviours serve as maladaptive coping mechanisms for aversive emotions. EFST aims to build skills in parents that foster adaptive emotional regulation for their children.

During the study, observations that are taken consist of weight, height, treatments undertaken (including completion/non-completion), hospitalisations during treatment (including length) and diagnoses. Measures the that the young people complete consist of the Eating Disorders Examination Questionnaire, Clinical Impairment Assessment, Patient Health Questionnaire, Child Anxiety Scale, Yale Brown Cornell Eating Disorder Scale, Child Post-traumatic Stress scale, Obsessive Compulsive Inventory Child-version, Borderline Personality Features Scale, Strengths and Difficulties Questionnaire, Autism Spectrum Quotient, Interpersonal Relationships in Eating Disorders Scale, Distress Intolerance Inventory, Dflex, Frost Multidimensional Perfectionism Scale, Rosenburg Self-Esteem Scale, Compulsive Exercise Scale, and the Brief Dyadic Scale of Expressed Emotion. Questionnaires are completed on tablet devices and are anticipated to take between 30-40 minutes to complete.

Measures that parents complete consist of the Eating Disorders Examination, Patient Health Questionnaire, Generalised Anxiety Disorder 7, Post-traumatic Symptoms Checklist, Parent Versus Anorexia Scale, Brief Dyadic Scale of Expressed Emotion, Eating Disorder Symptom Impact Scale, and the Accomodation and Enabling Scale for Eating Disorders. Questionnaires are completed on tablet devices and are anticipated to take between 30-40 minutes to complete.

The overall duration of observation will be from time of enrolment to discharge from the service. A typical treatment length at EDP is from 6-12 months, with treatment episodes longer than 2 years being unusual.
Intervention code [1] 328204 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337692 0
The primary outcome measures will be remission of eating disorder symptomology. This will be calculated as a binary outcome measure (i.e. remitted or not remitted), for each group
Timepoint [1] 337692 0
Start of treatment, change of treatment, discharge
Secondary outcome [1] 432856 0
Impact of the eating disorder on psychosocial functioning
Timepoint [1] 432856 0
Start of treatment, change of treatment, discharge
Secondary outcome [2] 432857 0
depression
Timepoint [2] 432857 0
Start of treatment, change of treatment, discharge

Eligibility
Key inclusion criteria
The EDP is a specialist service, such that all consumers are assessed for an eating disorder to be appropriate for treatment at the clinic. All consumers deemed suitable for the CYMHS EDP treatment as part of normal assessment procedures will be eligible for inclusion in the study. Suitability for treatment at CYMSH EDP requires being below 18 years of age; meeting criteria for an eating disorder and this being the primary clinical concern; willing/able to engage in treatment; and having medically or psychologically stability such that outpatient treatment is indicated.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To have adequate power (80%) to detect a 20% difference in remission status at end of treatment between two groups (e.g., FBT vs CBT-E) will be 50 individuals per group. To test the unique predictors of outcome with 80% power, 76 individuals per group will be required. A two tailed alpha of .05 will be used to evaluate all tests of significance. Power calculations are based off previous prior studies investigating moderators of two forms of FBT treatment (e.g., Le Grange et al., 2016).

Groups will be measured at treatment completion using intention-to-treat analysis. Logistic regression will be used to assess the effect of treatment group (IV) on remission status. Moderator analysis will be conducted using logistic regression using treatment group (effect coded e.g., FBT = -1, CBT-E = 1), predictor, and treatment group x predictor interaction (i.e., test of moderation).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/12/2020
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
300
Accrual to date
218
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316072 0
Government body
Name [1] 316072 0
Queensland Health Clinical Research Fellowship
Country [1] 316072 0
Australia
Primary sponsor type
Hospital
Name
Children's Health Queensland Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 318247 0
None
Name [1] 318247 0
none
Address [1] 318247 0
Country [1] 318247 0
Other collaborator category [1] 282981 0
University
Name [1] 282981 0
University of Queensland
Address [1] 282981 0
Country [1] 282981 0
Australia
Other collaborator category [2] 282982 0
University
Name [2] 282982 0
Griffith University
Address [2] 282982 0
Country [2] 282982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314890 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314890 0
Ethics committee country [1] 314890 0
Australia
Date submitted for ethics approval [1] 314890 0
26/11/2020
Approval date [1] 314890 0
09/12/2020
Ethics approval number [1] 314890 0
HREC/20/QCHQ/67708

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133066 0
Dr Dan Wilson
Address 133066 0
Child and Youth Mental Health Service Eating Disorders Program, 34 Curd Street, Greenslopes, 4120, QLD
Country 133066 0
Australia
Phone 133066 0
+61 4 33979077
Fax 133066 0
Email 133066 0
[email protected]
Contact person for public queries
Name 133067 0
Dan Wilson
Address 133067 0
Child and Youth Mental Health Service Eating Disorders Program, 34 Curd Street, Greenslopes, 4120, QLD
Country 133067 0
Australia
Phone 133067 0
+61 4 33979077
Fax 133067 0
Email 133067 0
[email protected]
Contact person for scientific queries
Name 133068 0
Dan Wilson
Address 133068 0
Child and Youth Mental Health Service Eating Disorders Program, 34 Curd Street, Greenslopes, 4120, QLD
Country 133068 0
Australia
Phone 133068 0
+61 4 33979077
Fax 133068 0
Email 133068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be available due to privacy and confidentiality reasons.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.